Treatment-emergent AESI and hospitalization (liso-cel–treated set)
| AESI . | |||
|---|---|---|---|
| . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . |
| CRS or NEs, n (%) | |||
| Any grade | 26 (46) | 14 (56) | 40 (49) |
| Grade ≥3 | 7 (12) | 1 (4) | 8 (10) |
| CRS, n (%) | |||
| Any grade | 21 (37) | 12 (48) | 33 (40) |
| Grade 1 | 15 (26) | 8 (32) | 23 (28) |
| Grade 2 | 6 (11) | 4 (16) | 10 (12) |
| Grade ≥3 | 0 | 0 | 0 |
| Median time to onset of any-grade CRS (range), d | 4.0 (1-9) | 3.0 (1-9) | 4.0 (1-9) |
| Median time to onset of grade ≥3 CRS (range), d | NA | NA | NA |
| Median time to resolution of any-grade CRS (range), d | 5.0 (1-15) | 4.5 (1-15) | 5.0 (1-15) |
| Median time to resolution of grade ≥3 CRS (range), d | NA | NA | NA |
| NEs, n (%) | |||
| Any grade | 16 (28) | 8 (32) | 24 (29) |
| Grade 1 | 5 (9) | 2 (8) | 7 (9) |
| Grade 2 | 4 (7) | 5 (20) | 9 (11) |
| Grade 3 | 5 (9) | 1 (4) | 6 (7) |
| Grade 4 | 2 (4) | 0 | 2 (2) |
| Grade 5 | 0 | 0 | 0 |
| Median time to onset of any-grade NEs (range), d | 8.0 (3-33) | 7.0 (3-16) | 7.5 (3-33) |
| Median time to onset of grade ≥3 NEs (range), d | 10.0 (8-33) | 3.0 (3-3) | 9.5 (3-33) |
| Median time to resolution of any-grade NEs (range), d | 9.0 (1-47) | 9.5 (3-35) | 9.0 (1-47) |
| Median time to resolution of grade ≥3 NEs (range), d | 21.0 (7-47) | 5.0 (5-5) | 16.5 (5-47) |
| Treatment with tocilizumab and/or corticosteroids for CRS or NEs, n (%) | 15 (26) | 9 (36) | 24 (29) |
| Tocilizumab only | 1 (2) | 3 (12) | 4 (5) |
| Corticosteroids only | 4 (7) | 6 (24) | 10 (12) |
| Both tocilizumab and corticosteroid | 10 (18) | 0 | 10 (12) |
| Infections,∗ n (%) | |||
| Any grade | 19 (33) | 8 (32) | 27 (33) |
| Grade ≥3† | 7 (12) | 2 (8) | 9 (11) |
| Grade ≥3 prolonged cytopenias at day 29,‡ n (%) | 19 (33) | 8 (32) | 27 (33) |
| Grade ≥3 decreased hemoglobin at day 29, n (%) | 6 (11) | 3 (12) | 9 (11) |
| Median time to recovery to grade ≤2 in 8 patients (range),§ d | 5.5 (3-22) | 22.0 (15-29) | 9.0 (3-29) |
| Grade ≥3 decreased platelets at day 29, n (%) | 15 (26) | 5 (20) | 20 (24) |
| Median time to recovery to grade ≤2 in 12 patients (range),|| d | 20.5 (5-39) | 29.0 (8-136) | 22.0 (5-136) |
| Grade ≥3 decreased neutrophils at day 29, n (%) | 9 (16) | 6 (24) | 15 (18) |
| Median time to recovery to grade ≤2 in 13 patients (range),¶ d | 12.5 (4-33) | 8.0 (8-32) | 10.0 (4-33) |
| Hypogammaglobulinemia, n (%) | |||
| Any grade | 8 (14) | 3 (12) | 11 (13) |
| Grade ≥3 | 0 | 0 | 0 |
| SPM, n (%) | |||
| Any grade | 0 | 1 (4) | 1 (1) |
| Grade ≥3 | 0 | 0 | 0 |
| AESI . | |||
|---|---|---|---|
| . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . |
| CRS or NEs, n (%) | |||
| Any grade | 26 (46) | 14 (56) | 40 (49) |
| Grade ≥3 | 7 (12) | 1 (4) | 8 (10) |
| CRS, n (%) | |||
| Any grade | 21 (37) | 12 (48) | 33 (40) |
| Grade 1 | 15 (26) | 8 (32) | 23 (28) |
| Grade 2 | 6 (11) | 4 (16) | 10 (12) |
| Grade ≥3 | 0 | 0 | 0 |
| Median time to onset of any-grade CRS (range), d | 4.0 (1-9) | 3.0 (1-9) | 4.0 (1-9) |
| Median time to onset of grade ≥3 CRS (range), d | NA | NA | NA |
| Median time to resolution of any-grade CRS (range), d | 5.0 (1-15) | 4.5 (1-15) | 5.0 (1-15) |
| Median time to resolution of grade ≥3 CRS (range), d | NA | NA | NA |
| NEs, n (%) | |||
| Any grade | 16 (28) | 8 (32) | 24 (29) |
| Grade 1 | 5 (9) | 2 (8) | 7 (9) |
| Grade 2 | 4 (7) | 5 (20) | 9 (11) |
| Grade 3 | 5 (9) | 1 (4) | 6 (7) |
| Grade 4 | 2 (4) | 0 | 2 (2) |
| Grade 5 | 0 | 0 | 0 |
| Median time to onset of any-grade NEs (range), d | 8.0 (3-33) | 7.0 (3-16) | 7.5 (3-33) |
| Median time to onset of grade ≥3 NEs (range), d | 10.0 (8-33) | 3.0 (3-3) | 9.5 (3-33) |
| Median time to resolution of any-grade NEs (range), d | 9.0 (1-47) | 9.5 (3-35) | 9.0 (1-47) |
| Median time to resolution of grade ≥3 NEs (range), d | 21.0 (7-47) | 5.0 (5-5) | 16.5 (5-47) |
| Treatment with tocilizumab and/or corticosteroids for CRS or NEs, n (%) | 15 (26) | 9 (36) | 24 (29) |
| Tocilizumab only | 1 (2) | 3 (12) | 4 (5) |
| Corticosteroids only | 4 (7) | 6 (24) | 10 (12) |
| Both tocilizumab and corticosteroid | 10 (18) | 0 | 10 (12) |
| Infections,∗ n (%) | |||
| Any grade | 19 (33) | 8 (32) | 27 (33) |
| Grade ≥3† | 7 (12) | 2 (8) | 9 (11) |
| Grade ≥3 prolonged cytopenias at day 29,‡ n (%) | 19 (33) | 8 (32) | 27 (33) |
| Grade ≥3 decreased hemoglobin at day 29, n (%) | 6 (11) | 3 (12) | 9 (11) |
| Median time to recovery to grade ≤2 in 8 patients (range),§ d | 5.5 (3-22) | 22.0 (15-29) | 9.0 (3-29) |
| Grade ≥3 decreased platelets at day 29, n (%) | 15 (26) | 5 (20) | 20 (24) |
| Median time to recovery to grade ≤2 in 12 patients (range),|| d | 20.5 (5-39) | 29.0 (8-136) | 22.0 (5-136) |
| Grade ≥3 decreased neutrophils at day 29, n (%) | 9 (16) | 6 (24) | 15 (18) |
| Median time to recovery to grade ≤2 in 13 patients (range),¶ d | 12.5 (4-33) | 8.0 (8-32) | 10.0 (4-33) |
| Hypogammaglobulinemia, n (%) | |||
| Any grade | 8 (14) | 3 (12) | 11 (13) |
| Grade ≥3 | 0 | 0 | 0 |
| SPM, n (%) | |||
| Any grade | 0 | 1 (4) | 1 (1) |
| Grade ≥3 | 0 | 0 | 0 |
| Hospitalizations . | ||
|---|---|---|
| . | Outpatients (n = 57) . | Inpatients (n = 25) . |
| Patients hospitalized, n (%) | 43 (75) | 25 (100) |
| Median time to initial hospitalization in outpatients (range), d | 5.0 (2-310) | NA# |
| Time to initial hospitalization in outpatients, n (%) | ||
| Within 72 h after day of infusion | 18 (32) | NA |
| 72 h to 29 d after day of infusion | 15 (26) | NA |
| >29 d after day of infusion | 10 (18) | NA |
| Not hospitalized | 14 (25) | NA |
| Median duration of initial hospitalization (range), d | ||
| All hospitalized patients | 6.0 (1-28) | 15.0 (3-31) |
| Patients hospitalized within 72 h after day of infusion | 9.5 (4-28) | NA |
| ICU stays during initial hospitalization | ||
| Patients admitted to the ICU, n (%) | 1 (2) | 2 (8) |
| Median duration of ICU admission (range), d∗∗ | 5.0 (5-5) | 5.5 (4-7) |
| Hospitalizations . | ||
|---|---|---|
| . | Outpatients (n = 57) . | Inpatients (n = 25) . |
| Patients hospitalized, n (%) | 43 (75) | 25 (100) |
| Median time to initial hospitalization in outpatients (range), d | 5.0 (2-310) | NA# |
| Time to initial hospitalization in outpatients, n (%) | ||
| Within 72 h after day of infusion | 18 (32) | NA |
| 72 h to 29 d after day of infusion | 15 (26) | NA |
| >29 d after day of infusion | 10 (18) | NA |
| Not hospitalized | 14 (25) | NA |
| Median duration of initial hospitalization (range), d | ||
| All hospitalized patients | 6.0 (1-28) | 15.0 (3-31) |
| Patients hospitalized within 72 h after day of infusion | 9.5 (4-28) | NA |
| ICU stays during initial hospitalization | ||
| Patients admitted to the ICU, n (%) | 1 (2) | 2 (8) |
| Median duration of ICU admission (range), d∗∗ | 5.0 (5-5) | 5.5 (4-7) |
NA, not applicable; SPM, second primary malignancy.
Includes all TEAEs from the infections and infestations System Organ Class.
Grade ≥3 infections among outpatients included sepsis (n = 3) and bacteremia, COVID-19, C difficile infection, fungal skin infection, pneumonia, urinary tract infection, and urosepsis (n = 1 each); among inpatients, sepsis and C difficile colitis (n = 1 each).
Any grade ≥3 laboratory results of anemia, neutropenia, or thrombocytopenia at day 29 after liso-cel infusion.
Recovery data are presented for the 6 outpatients and 2 inpatients who had hemoglobin laboratory results after day 29.
Recovery data are presented for the 10 outpatients and 2 inpatients who had platelet laboratory results after day 29.
Recovery data are presented for the 8 outpatients and 5 inpatients who had neutrophil laboratory results after day 29.
Time to initial hospitalization was NA in inpatients, because all inpatients were already hospitalized for monitoring.
For inpatients, calculated as date of discharge minus first liso-cel dose date plus 1. For outpatients, calculated as date of discharge minus date of admission after liso-cel administration plus 1.